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公司一个系统安装了几个监测数据的探头,可是得到的数据都略有差别
经常校验,统一,但是没过多久又出现差别
偏差也没有办法解决
看到了MHRA的数据完整性资料提到了primary record
Primary Record: In the event that primary data are recorded simultaneously by multiple systems, the system that generates and stores the data has to be defined. A risk assessment respectively a risk management has to ensure that the so-defined primary records have the maximum possible accuracy, completeness and relevance. It is not allowed to define so-called static data (prints or manual records), if there are dynamic (electronic) data as primary records. If there are data anomalies (e.g. OOS results), all data (static and dynamic) will have to be included in a risk-based investigation
即通过风险评估确定一个系统采集的数据为准即可
当然重在“风险评估”!
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